Directorate General of Health Services classified the newly notified medical devices

May 21, 2019 | by Avantis RegTech Legal Research Team


The Directorate General of Health Services on May 15, 2019, has classified the newly notified medical devices under the provisions of the Drugs and Cosmetics Act, 1940.

The newly notified categories and its class of Risk are:

1.CT scan Equipment – Class C

2.MRI Equipment – Class C

3.Defibrillators – Class C

4.Dialysis Machine – Class C

5.PET Equipment – Class C

6.X-Ray Machine – Class C

7.Bone marrow cell separator – Class B

8.Nebulizer – Class C

9.Blood Pressure Monitoring Devices – Class B

10.Digital Thermometer – Class B

11.Glucometer – Class C

12.Organ Preservative Solution – Class C


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